AAMI/ISO TIR80002-2:2017 (PDF)

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This document applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.

Date of Publication: 18 August 2017

Pages: 103

ISBN: 978-1-57020-670-2